Restriction & Double Patenting

Mojdeh Bahar, J.D., M.A., CLPChief, Cancer BranchOffice of Technology TransferNational Institutes of HealthU.S. Department of Health & Human Services

Road Map

Restriction Definition Types Linking Claim Rejoinder Restriction vs. Unity of Invention

Double Patenting Statutory Non-Statutory

Questions

Restriction: Definition & Characteristics

A tool used by the USPTO to limit the substantive examination of a patent application to a single invention

Set forth in 35 USC 121 It is discretionary It can be set forth any time during prosecution A proper restriction requirement establishes:

The existence of two or more independent or distinct inventions (See MPEP §802; §806), and a

serious burden on the examiner (See MPEP §803.02; §806.04; §808.01-02), e.g., separate status in the art; separate classification; divergent field of search

Example of Distinct Inventions

The application contains claims to different inventions: polypeptides polynucleotides antibodies diagnostic kit

Applicant must elect an invention for examination Election may be done with or without traverse. If the

restriction is traversed, applicant can petition to Group Director.

Divisional Application may be filed covering non-elected invention

Categories of Related Inventions

Product and process of use; MPEP§806.05 (h) Product and Process of making; MPEP§806.05 (f) Process and apparatus for its practice; MPEP§806.05 (e) Apparatus and product; MPEP§806.05 (g) Combination and subcombination ; MPEP§806.05 (a-c) Subcombinations useable together; MPEP§806.05 (d) Intermediate and final product MPEP§806.04(b) Product, process of making, process of using MPEP§806.05 (i)

Linking Claims: Definition and Characteristics

One or more claims inseparable from claims to two or more otherwise properly divisible invention; MPEP §809.

If deemed allowable, restriction must be withdrawn.

Upon withdrawal of the restriction, double patenting rejections may come in to play; protection of 35 USC 121 is no longer afforded

Example of a Linking Claim

1. A pharmaceutical composition comprising an inorganic or an organic compound.

2. The pharmaceutical composition of claim 1 wherein the organic compound is an estrogen.

3. The pharmaceutical composition of claim 1 wherein the inorganic compound is water.

4. A method of treating infertility using the pharmaceutical composition of claim 1.

Rejoinder

If the invention under examination is a product, once the product has been deemed allowable, the process of making and using the same must be allowed as well.

In re Ochiai; MPEP 821.04 Sua sponte rejoinder by the USPTO Process of making and using claims must be of the

same scope as the product claims

Restriction vs. Unity of Invention

For 111 applications (applications filed under 35 USC 111) the standard is set forth in 35 USC 121; the standard is expressed as “independent”, “distinct”, “related” inventions

For 371 applications (applications filed under 35 USC 371), the standard is 35 USC 372 and 35 USC 121; the standard is expressed as “unity of invention”, “common technical feature”

Divisional Application and Non-Elected Subject matter

Independent or distinct invention carved out of a pending application claiming only subject matter disclosed in the earlier application, i.e., non-elected invention Diagnostic kit Antibodies polynucleotides

Filed in response to a restriction requirement The priority date is the original application’s priority

date A divisional application cannot be subject to a DP

rejection over its parent application/patent.

Double Patenting: Purpose & Types

The purpose of DP rejections is to prevent unjustified extension of patent term

DP rejections are based on an issued patent or pending patent application with the same assignee

There are two types of Double patenting rejections:

Statutory Double Patenting under 35 USC §101 Non-Statutory Double Patenting which is based on

anticipation or obviousness analyses

Statutory Double Patenting : Characteristics and Cure

Identical subject matter is being claimed in the claims under examination and those of a commonly owned patent or patent application

The claims under examination and those in a commonly owned patent or patent application encompass the same embodiments

Claims subject to the DP rejection must be cancelled or amended

A terminal disclaimer does not overcome a DP rejection under 35 USC 101

Non-Statutory Double Patenting

It can be based on a anticipation or obviousness type analyses

It can be overcome by cancelling or amending the claim

It can also be overcome by a terminal disclaimer

Questions

Thank you for your kind attention